Udenafil

Unassigned

New Medicines

Congenital heart disease after fontan palliation in adolescents

Information

New molecular entity
Mezzion
Mezzion

Development and Regulatory status

None
None
Phase III Clinical Trials
Yes
Oct 19 · Mezzion announced that based on the discussions with FDA, the company is taking necessary steps to prepare and submit an NDA based upon the results of the PIII FUEL trial [3]

Category

A small-molecule, pyrazolopyrimidinone derivative that inhibits type 5 cyclic nucleotide phosphodiesterase.
Congenital heart disease is one of the most common types of birth defect, affecting up to 8 in every 1,000 babies born in the UK. Operative mortality of the Fontan procedure has steadily decreased and is currently <2% [1].
Congenital heart disease after fontan palliation in adolescents
Oral

Evidence based evaluations